7402 Shellfish Sanitation Regulations

1.0 Introduction

International standards for shellfish (molluscan bivalves only) growing area water quality, as well as shellfish growing, harvesting, handling, and processing, are maintained by the Interstate Shellfish Sanitation Conference (ISSC), administrative body of the National Shellfish Sanitation Program (NSSP). Adherence to these standards is a voluntary, cooperative effort by NSSP member states and foreign countries. Member states and countries allow shipment of shellfish into their jurisdictions only from other member states and countries that adhere to ISSC standards and practices. Delaware is an ISSC member, along with 27 other states, the District of Columbia, and nine foreign countries. The NSSP evolved from public health principles and program controls formulated at the original conference on shellfish sanitation called by the Surgeon General of the United States Public Health Service in 1925. Adherence to ISSC standards is administered under the auspices of the U.S. Food and Drug Administration.

The purpose of these Regulations is to ensure that the shellfish harvested for any purpose from Delaware waters, and shellfish shipped to Delaware from beyond it's borders, are fit for human consumption - to protect the public health and safety. This "strategic theme" of Delaware's Shellfish Program is proscribed in the Environmental Partnership Agreement between Delaware's Department of Natural Resources and Environmental Control and the U.S. Environmental Protection Agency, Region III. Under this Agreement, key environmental problems and priorities are identified, and key goals established to address them. By protecting the health and safety of shellfish consumers, these Regulations also serve to promote and enhance Delaware's multi-million-dollar shellfish industry, protect the interests of recreational shellfish harvesters, keep as much shellfish ground open to harvesting as environmental conditions allow, and to broadly advocate clean water.

Consumer Warning: Certain people may be at risk of serious illness or death as a result of consuming raw molluscan shellfish, including those with liver disease (from hepatitis, cirrhosis, alcoholism, or cancer), Iron Overload Disease (hemochromatosis), diabetes, those with stomach disorders, including; but not limited to those with low stomach acid, those with immune system disorders, or those with any illness or medical treatment that weakens the body's immune system. Physicians recommend that those at risk not eat any clams, mussels, oysters, or scallops, and furthermore recommend that shellfish, if consumed by the at-risk population, be thoroughly cooked.

2.0 Definitions

NOTE: Those definitions primarily relating to the "Policy To Determine Shellfish Growing Area Classification In And Around Wet Slip Basins And Artificial Lagoons" are contained in Appendix 11.

Approved HACCP Plan (see HACCP): An operational plan mandated by Federal law, effective as of December 18, 1997, and defined in the Federal Register in the "Procedures For the Safe and Sanitary Processing and Importation Of Fish and Fishery Products; Final Rule." which includes Part 123: "Fish and Fishery Products Hazards and Controls Guide," and which is approved by DNREC.

Approved HACCP Training Course: A course approved by DNREC in the instruction of HACCP concepts and operational specifications, mandated by Federal law, effective as of December 18, 1997, and defined in the Federal Register in the "Procedures For the Safe and Sanitary Processing and Importation Of Fish and Fishery Products; Final Rule." which includes Part 123: "Fish and Fishery Products Hazards and Controls Guide."

Approved Depuration Process: The process of reducing bacteria and virus levels to acceptable levels in live shellfish by subjecting them to a strictly controlled aquatic environment, as performed only by a certified depuration processor.

Approved Relaying Operation: The harvesting of shellfish from waters classified as other-than-Approved; however not Prohibited, and their subsequent transference to natural bottom, or in approved containers, to Approved shellfish growing areas; however only with written permission of DNREC.

Approved Source of Shellfish: Shellfish meeting all criteria in these Regulations, including the following:

Back Flow/Back Siphonage: Water intended as a potable source; however carrying, or potentially carrying poisonous and/or deleterious substances, because this water flows in the opposite direction of the intended flow due to negative pressure in the potable water supply system.

Business: A shellfish-related business, entity, person, or persons.

Buy Boat/Buy Truck: A boat/truck which is used for the purchasing/shipment of shellfish in the capacity of a certified shellfish dealer/processor.

Certification: The issuance of a numbered license or permit to operate as an intrastate or interstate shellfish dealer/processor.

Certification Number: A number assigned to each certified shellfish dealer/processor by DNREC. The number shall be proceeded by the letters "DE" to indicate Delaware, and followed by a two letter symbols designating the type of operation.

Certified Shellfish Dealer/Processor: A person, persons, or business (including buildings, trucks, boats, and other equipment) which engage in one or more of the following: the sale, shucking, packing, repacking, shipping, reshipping, depurating, freezing, or other handling of shellfish on an interstate and/or intrastate basis, as follows:

Commingling: The act of combining different lots of shucked or unshucked shellfish.

Cross Connection: A potable water supply line constructed to allow either back siphonage, or the attachment of a supply line extension which would allow back siphonage.

DNREC: The Delaware Department of Natural Resources and Environmental Control.

Depuration Plant: A plant certified by the State Shellfish Control Authority as a depuration processor.

Depuration Processor (DP): A shellfish dealer/processor which receives or harvests shellstock from approved sources; OR shellfish from waters classified as Seasonally Approved, Conditionally Approved, or Restricted, and which subjects this shellfish to an approved depuration process thereby rendering the shellfish as approved and fit for human consumption; however only as approved by DNREC.

Depuration Process Specifications: The controlled conditions (physical and operational specifications) by which shellfish are subjected to a strictly controlled aquatic environment as a means of reducing the levels of bacteria and viruses in live shellfish to acceptable levels, as approved by DNREC.

Depuration Unit: A tank, trough, or similar vessel in which live shellfish are stored temporarily, and subjected to depuration.

Dry storage: The storage of shellstock out of water.

EPA: The United States Environmental Protection Agency.

FDA: The United States Food and Drug Administration.

Food Contact Surface: Those surfaces of equipment and utensils which normally come in contact with food, and those surfaces from which food may drain, drip, or splash back onto surfaces normally in contact with food.

Food-Product Zone: The parts of food equipment, including ancillary structures, such as blower pipes and drain valves, which may contact the food being processed, or may drain into the portion of equipment with which food is in contact.

HACCP (Hazard Analysis Critical Control Points): A method of conducting sanitation assessments of shellfish/seafood dealer/processors, mandated by Federal law, effective as of December 18, 1997, and defined in the Federal Register as the "Procedures For the Safe and Sanitary Processing and Importation Of Fish and Fishery Products; Final Rule." which includes Part 123: "Fish and Fishery Products Hazards and Controls Guide."

Harvester Tag: A tag required to be affixed by a commercial shellfish harvester to an individual unit of shellfish, and meeting specifications contained in Appendix-10.

Harvest Lot: Shellfish harvested from one shellfish growing area during a single harvesting operation by a single shellfish harvester (for example: a harvester's daily take from a single growing area).

Internal Temperature: The actual temperature of shucked shellfish in the container (not necessarily the air temperature of the refrigerator in which the product may be stored).

Intrastate Shellfish Retailer: A shellfish dealer/processor which sells shellfish only in Delaware.

Marine Head: A toilet or other human waste catchment device with retention and/or discharge capability. A marine head may or may not be an MSD. MSD is the term for a Coast Guard approved marine head. See Appendix-11 for a more detailed definition.

National Shellfish Sanitation Program (NSSP): The cooperative State-FDA-Industry Program for certification of foreign and domestic interstate shellfish dealer/processors as described in the “NSSP Model Ordinance."

Person: A person as defined in Title 1, Chapter 3, Section 302, Delaware Annotated Code.

Poisonous or Deleterious Substance: A toxic compound occurring naturally, or which is artificially introduced.

Polluted Waters: Waters which contain human pathogenic organisms and/or indicator organisms and/or other poisonous/deleterious substances at actual or theoretical levels which are determined to render the shellfish growing in the waters unfit for human consumption.

Process Lot: A harvest lot or lots from the same shellfish growing area which are subject to processing.

Process Water: The water in depuration tanks when shellfish are present.

Relay Lot: All shellfish harvested from a single shellfish growing area and transported to another shellfish growing area for natural biological purification.

Relay Operator: A person/business permitted/certified to engage in relaying.

Repacker (RP): A shellfish dealer/processor, other than the original certified shucker-packer, which repacks and ships shucked shellfish into containers other than the original container.

Sanitary Survey: The collection of valid dilution formula loading factors, all elements of a wet slip basin classification survey, and the evaluation of all other actual and potential pollution sources and environmental factors having a bearing on shellfish growing area water quality.

Sewage: Human body wastes and/or other wastes from toilets and other receptacles intended to receive and discharge and/or retain such wastes.

Shellfish: All edible species of oysters, clams, mussels and scallops* either shucked or in the shell, fresh or frozen, whole or in part. The term "shellfish" may be used interchangeably with "shellstock" unless otherwise specified in these Regulations. Some of the common bivalves included in this definition are:

Common Name Scientific Name

Cockle Clinocardium nuttalli

Cardium corbis (Pacific)

Geoduck Panope generosa

Freshwater clam Rangia cuneata

Soft shell clam Mya arenaria

Hard or quahog clam Mercenaria mercenaria

Mercenaria campechiensis

Surf clam Spisula solidissima

Mahogany clam or Ocean quahog Arctica islandica

Gaper or Horse clam Tresus nuttalli

Tresus capax

Razor clam Solen resaceus

Ensis directus (Atlantic)

Solen viridis

Tagelus plebeius

Siliqua patula (Pacific)

Bent-nose clam Macoma nasuta

Pismo clam Tivela stultorum

Butter clam Saxidomus giganteus

Calico clam Macrocallista maculata

Sunray venus Macrocallista nimbosa

Pacific littleneck clam Protothaca tenerrima

Protothaca staminea

Manilla clam Tapes semidecussata

Pacific (Japanese) oyster Crassostrea gigas

Eastern oyster Crassostrea virginica

Olympia or yaquina oyster Ostrea lurida

European oyster Ostrea edulis

Blue or bay mussel Mytilus edulis

Ribbed mussel Geukensia demissa

California sea mussel Mytilus californianus

Green lipped mussel Perna canaliculus

*Scallops are excluded if the final product is the shucked adductor muscle only.

Shellfish Growing Areas (Waters): Naturally-occurring subaqueous or intertidal areas which support or could support live shellfish.

Shellfish Growing Area Classification: A designation which reflects the suitability of an area for shellfish harvesting relating to the fitness of the shellfish therein for human consumption. The following are the classifications that Delaware may use:

Shellfish Handling: Any manual, mechanical, chemical manipulation or alteration of shellfish relating to its growing, harvesting, buying, treating, packing, selling, shipping, or other processing.

Shellfish Handler: Any person, persons, or business engaged in the growing, harvesting, buying, treating, packing, selling, shipping or other processing of shellfish.

Shellfish Harvester (Catcher, Taker, Tonger, etc.): A person who removes shellfish from any waters by any means for any purpose.

Shellfish Harvesting (Catching, Taking, Tonging, Raking, etc.): The removal of shellfish by any means from a shellfish growing area for any purpose.

Shellfish Processing: The process undertaken when shellfish are shipped, reshipped, shucked, frozen, packed, repacked, depurated, or otherwise handled.

Shellstock: Shellfish in the shell.

Shellstock-Shipper (SS): A shellfish dealer/processor which grows, and/or harvests, and/or buys, and sells/ships shellstock.

Shellstock Shipper Tag: A tag required to be affixed by a shellstock shipper, repacker, or shucker-packer, to an individual unit of shellfish (as defined in these Regulations), and meeting specifications contained in Appendix 10.

Shucked Shellfish: Shellfish, whole or in part, from which one or both shells have been removed.

Shucker-Packer (SP): A shellfish dealer/processor which shucks and packs shellfish, and may also act as a SS or RS.

State Shellfish Control Authority (SSCA): The State agency or agencies having legal authority to classify shellfish growing areas and issue permits for the interstate shipment of shellfish in accordance with the provisions of the "NSSP Model Ordinance." Foreign shellfish control authorities having effective agreements with the FDA are considered State Shellfish Control Authorities for the purposes of these Regulations. DNREC is the State Shellfish Control Authority for Delaware.

Transaction Record: Forms used to document each purchase or sale of shellfish at the wholesale level.

Wet Storage: The temporary storage of shellfish intended for marketing in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater.

Wet Slip: A place in the water where a boat may be docked or otherwise moored to a fixed or floating structure, including but not limited to a dock, pier, mooring or anchorage.

Wet Slip Basin: A natural waterway and/or artificial lagoon and/or demarcated portions thereof containing more than ten wet slips.

3.0 General Regulations, Water Quality and Classification, Harvesting, Tracking, Permitting, Handling and Shipping:

3.1 General Regulation Specifications:

3.1.1 DNREC Authority: These Regulations are adopted under authority of Title 7 of the Delaware Annotated Code. These Regulations shall be applied and enforced by DNREC in accordance with the specifications contained herein, and based on the interpretation of satisfactory compliance contained in the latest editions of the "NSSP Model Ordinance." Any person who neglects or fails to comply with any provision of these Regulations shall be subject to penalty.

3.1.1.1 These Regulations shall supersede and replace the Regulations Governing the Production, Handling, Processing, Transportation, and Sale Of Shellfish, and shall apply throughout the State of Delaware.

3.1.2 Unconstitutionality Clause: Should any section, paragraph, sentence, clause, or phrase of these regulations be declared unconstitutional or invalid for any reason the remainder of said regulations shall not be affected thereby.

3.1.3 Seizure of Shellfish: Shellfish which are determined to be adulterated, or which can not be identified as to source or place or origin, shall be seized, confiscated, and destroyed by DNREC. DNREC shall possess the authority to seize, confiscate, and destroy shellfish in the event of significant non-compliance with these regulations which could result in an eminent health hazard, as determined by DNREC.

3.1.4 Certification/Permitting/Sanitary Control: Not all persons/businesses handling shellfish shall necessarily be required to be permitted/certified by DNREC. However, persons/businesses which handle shellfish shall be permitted/certified by DNREC as per these regulations; and all persons or businesses which handle shellfish shall be under the sanitary control of DNREC. Certification, permits or written permission shall be non-transferable.

3.1.5 Emergency Closure of Shellfish Growing Areas: Emergency closure of shellfish growing areas to shellfish harvesting may be implemented by DNREC in response to the introduction of contaminants into shellfish growing waters, or in response to events which could affect the introduction of contaminants into shellfish growing waters, including; but not limited to: storms, flooding, sewage treatment plant failures, spills, boat wastes, or toxin-producing phytoplankton blooms (see Appendix 8).

3.1.6 HACCP (Hazard Analysis Critical Control Point): HACCP shall take effect on December 18, 1996. DNREC shall regulate under HACCP only those shellfish dealer/processors which are listed in the Interstate Certified Shellfish Shippers List, and which fall under HACCP as defined in Section 123.3 (k) (1) of the Federal law mandating HACCP, as interpreted by DNREC, and shall regulate only the portion or portions of said operation / physical facility which is/are utilized in the receipt, handling, processing, and shipping, of said shellfish, as defined herein.

3.2 Shellfish Growing Area Water Quality, Classification, and Harvesting:

3.2.1 Shellfish Growing Area Water Quality and Classification:

3.2.1.1 DNREC shall determine the size, configuration and classification of shellfish growing areas in Delaware.

3.2.1.2 DNREC shall determine the validity of all information which may have a bearing on the determination of the size, configuration, and classification of shellfish growing areas in Delaware.

3.2.1.3 DNREC shall classify Delawares's shellfish growing areas on the basis of the following:

3.2.1.3.1 Theoretical pollution loading including; but not limited to areas determined to be impacted by wet slip basins, as per the specifications contained in Appendix 11, thereby constituting an administrative closure;

3.2.1.3.2 Sanitary survey data constituting the documented presence of actual and potential point-source and non-point pollution sources; and

3.2.1.3.3 Bacteriological monitoring of shellfish growing waters and/or shellfish tissue (see Appendix 4).

3.2.1.4 Delaware's shellfish growing waters shall be classified as Approved, Prohibited, Seasonally Approved, Conditionally Approved, or Restricted.

3.2.1.5 Conformance with bacteriological shellfish water quality standards shall be based on a geometric average of the most recent 30 samples per sample station.

3.2.1.6 Seasonally Approved and Conditionally Approved shellfish growing areas shall meet the following bacteriological standards on a seasonal and/or conditional basis depending upon the specifications of the classification/condition(s); and Approved shellfish growing areas shall meet the following bacteriological standards at all times:

3.2.1.6.1 Total coliform mean MPN levels in shellfish growing waters shall not exceed 70 per 100 ml and not more than 10% of the samples shall exceed an MPN of 230 per 100 ml for a 5-tube decimal dilution test, or an MPN of 330 per 100 ml for a 3-tube decimal dilution test.

AND/OR

3.2.1.6.2 Fecal coliform mean MPN levels in shellfish growing waters shall not exceed 14 per 100 ml and not more than 10% of the samples shall exceed an MPN of 43 per 100 ml for a 5-tube decimal dilution test, or an MPN of 49 per 100 ml for a 3-tube decimal dilution test.

3.2.1.7 The standard for the Restricted classification of growing areas for purposes of relay or depuration of the shellfish therein shall be a total coliform mean MPN level in said growing waters of 700 per 100 ml. and not more than 10% of the samples shall exceed an MPN of 3,300 per 100 ml. using a 3-tube decimal dilution test. This standard shall apply, and shall be applied, relating to any and all restrictions based on the effects by point or non-point sources of pollution, and/or other conditions as set forth in the latest edition of the NSSP Model Ordinance.

3.2.2 Shellfish Harvesting and Tagging:

3.2.2.1 Shellfish harvesting shall not be allowed in the following areas:

3.2.2.1.1 Shellfish growing areas classified as Prohibited, unless for scientific research purposes, and only with written permission of DNREC;

3.2.2.1.2 Shellfish growing areas classified as Seasonally Approved or Conditionally Approved in accordance with conditions stipulated in Appendix 3.

3.2.2.1.3 Shellfish growing areas not classified, and for which there are insufficient data supporting a harvest.

3.2.2.2 Shellfish may be harvested from the following areas under the conditions listed herein and/or in the Appendices:

3.2.2.2.1 In shellfish growing areas classified as Approved;

3.2.2.2.2 Shellfish growing areas classified as Seasonally Approved in accordance with conditions stipulated in Appendix 3;

3.2.2.2.3 Shellfish growing areas classified as Restricted.

3.2.2.3 Harvesters shall place tags on individual units of shellstock, recognizing that individual bags or a bulk landing of shellstock may constitute an individual unit of shellstock. All harvester tags shall meet the requirements specified in Appendix 10.

3.3 Permitting of Shellfish Dealer/Processors:

3.3.1 Permit Issuance Parameters:

3.3.1.1 Applications for permits to operate as shellfish dealer/processors shall be made on permit applications provided by DNREC. The following shellfish handlers shall be required to be permitted/certified by DNREC in order to engage in the procurement and sale of shellfish:

3.3.1.1.1 All interstate shellfish dealer/processors;

3.3.1.1.2 Intrastate shellfish dealer/processors;

3.3.1.1.3 Shellfish wholesalers;

3.3.1.1.4 Shellfish retailers which procure shellfish from non-certified sources;

3.3.1.1.5 Shellfish harvesters, engaged in:

3.3.1.1.5.1 Selling/shipping shellfish directly to non-certified shellfish retailers or to final consumers;

3.3.1.1.5.2 Owners of "buy boats" and "buy trucks;" and

3.3.1.1.5.3 Harvesting of shellfish for delivery to a depuration plant and/or for relaying.¹

¹Persons harvesting shellfish from waters classified as other-than-Approved for delivery to a depuration plant and persons engaged in relaying shall submit operational specifications for said activities to DNREC prior to commencing operations, and shall have received a permit or written permission from DNREC to harvest shellfish from waters classified as other-than-Approved prior to commencing such operations. Additional permits may be required by the DNREC Division of Fish and Wildlife.

3.3.1.2 Shellfish retailers shall not be required to be permitted/certified unless shellfish are procured from a non-certified source.

3.3.1.3 Shellfish handlers requiring a permit/certification shall not operate until and unless a permit/certification has been issued by DNREC. Such permits shall expire on the 31st day of March of each year. Permits shall not be transferable. No permit will be issued unless an application is made in writing upon forms supplied by DNREC. Prior to the physical and/or operational alteration of an existing facility and/or prior to initial commencement of shellfish processing operations shellfish dealer/processors shall:

3.3.1.3.1 Submit construction and operational specs. to DNREC;

3.3.1.3.2 Receive approval of the plans and operational specifications from DNREC;

3.3.1.3.3 Submit to an inspection of their plant/operation by DNREC; and

3.3.1.3.4 Shall be found to be in satisfactory compliance with these Regulations, at the discretion of DNREC.

3.3.1.4 DNREC shall have the authority to immediately revoke shellfish dealer/processor permits based on the existence of an eminent health hazard and/or significant and/or chronic non-compliance with these Regulations.

3.3.1.4.1 Delaware Shellfish Dealer/Processors shall be considered to be certified only if a current numbered license or permit to operate as an intrastate or interstate shellfish dealer/processor has been issued by DNREC, and the operation is in significant compliance with these regulations, as determined by DNREC.

3.3.2 Permit Specifications and Inspection Frequency:

3.3.2.1 The permits listed below shall be issued as interstate shellfish dealer/processor permits, OR intrastate shellfish dealer/processor permits; EXCEPT intrastate shellfish retailer permits which are issued as intrastate permits only. This includes all wholesalers, which shall also apply to harvesters which engage in the activities defined below and elsewhere in these Regulations:

3.3.2.1.1 Shellstock Shipper (SS) permit: Such permits may be issued to shellfish dealer/processors which ship shellfish. Said shellfish may be grown and/or harvested by the shipper in accordance with these Regulations and/or procured from another source. Shellstock shippers may procure shellfish directly from licensed Delaware shellfish harvesters, and may sell shellfish to other certified shellfish dealer/processors in and outside of Delaware and to the final consumer. Shellstock shippers shall not act as shucker-packers, repackers, or depuration-processors. Minimum Inspection Frequency: Twice/year.

3.3.2.1.2 Shucker-Packer (SP) permits: Such permits may be issued to shellfish dealer/processors which shuck and pack shellfish. Shucker-packers may act as shellstock-shippers and repackers. Shucker-packers shall not act as depuration-processors. Minimum Inspection Frequency: Once/month when operating, and at least four times per year, total, unless the facility is open less than four months per year.

3.3.2.1.3 Repackers (RP) permit: Such permits may be issued to shellfish dealer/processors other than the original certified shucker-packer which repack and ship shucked shellfish into other containers. Such permit-holders must generally meet more requirements than shellstock-shippers; however, not generally the equipment requirements of a shucker-packer. Repackers may act as shellstock-shippers. Repackers shall not act as shucker-packers or depuration-processors. Minimum Inspection Frequency: Once/month when operating, and at least four times per year, total, unless the facility is open less than four months per year.

3.3.2.1.4 Depuration Processor (DP) permit: Such permits shall be issued to shellfish dealer/processors which receive or harvest shellstock from approved sources, or as per criteria listed in the depuration portions of Section IV of these Regulations, and which subjects said shellfish to an approved depuration process, thereby rendering the shellfish as approved and fit for human consumption. A depuration-processor may act as a shellstock-shipper, or repacker. Minimum Inspection Frequency: Once/month when operating, and at least four times per year, total, unless the facility is open less than four months per year. twice/year.

3.3.2.1.5 Intrastate Shellfish Retailer permit: Such permits may be issued to persons/businesses located in Delaware, which may include vehicles registered only in Delaware and/or permanent structures from which shellfish are sold only to the final consumer. The intention of this permit is to provide sanitary control of shellfish not necessarily procured from a certified shellfish dealer/processor. Minimum Inspection Frequency: twice/year.

3.4 Shellfish Handling and Shipping Parameters:

3.4.1 Importation/Exportation:

3.4.1.1 Only shellfish from approved sources shall be imported into Delaware.

3.4.1.2 Only shellfish which have been handled by certified interstate shellfish dealer/processors shall be exported from Delaware.

3.4.1.3 Intrastate Delaware shellfish dealer/processors shall not sell/ship shellfish out of Delaware; and shellfish handled by intrastate Delaware shellfish dealer/processors shall not be made available for sale outside of Delaware.

3.4.1.4 Shellfish requiring depuration or relaying shall be sold/shipped only within Delaware to certified depuration-processors, or shall be shipped out of Delaware only under the provisions of interstate memoranda of agreement (MOAs) relating to a specific harvest/depuration or harvest/relaying operation by persons permitted to harvest shellfish under these restrictions, as established in writing by DNREC and the cooperating state. All other handling of shellfish from Prohibited waters and from Seasonally Approved or Conditionally Approved waters when the direct harvest of said shellfish is prohibited by these Regulations is prohibited.

3.4.2 Marketing to the Final Consumer:

3.4.2.1 Only shellfish from approved sources shall be sold/transferred in Delaware to the final consumer.

3.4.2.2 Certified interstate and intrastate shellfish dealer/processors may sell/transfer shellfish directly to the final consumer.

3.4.2.3 Certified interstate and intrastate shellfish dealer/processors may sell/transfer shellfish directly to non-certified shellfish retailers.

3.4.3 Sale/Shipping Between Shellfish Dealer/Processors.

3.4.3.1 Certified intrastate shellfish dealer/processors may sell/transfer shellfish to other intrastate shellfish dealer/processors.

3.4.3.2 Certified interstate shellfish dealer/processors may sell/transfer shellfish to other certified interstate shellfish dealer/processors or to Delaware intrastate shellfish dealer/processors.

3.4.3.3 Certified interstate and intrastate shellfish dealer/processors shall not sell/transfer shellfish to commercial establishments which are in critical or significant violation of these regulations at the discretion of DNREC.

4.0 HACCP and Sanitation: Harvesting, Handling, Processing, Depuration, and Relaying

4.1 HACCP (Hazard Analysis Critical Control Points): All HACCP specifications are contained in Appendix 12 of these Regulations, and consists of the "Fish and Fishery Products Hazards and Controls Guide, and the accompanying "Training Guide."

4.1.1 The HACCP method of doing sanitation assessments shall take effect on December 18, 1997. Until then, all portions of these Regulations shall be in effect. As of December 18, 1997, all portions of these Regulations superseded by HACCP shall no longer be in effect. However, the remainder of these Regulations shall not be affected thereby.

4.1.2 After December 18, 1996, a representative person from each Delaware shellfish dealer/processor businesses/operation, and which shall include only those shellfish dealer/processors which are listed in the Interstate Certified Shellfish Shippers List, and which fall under HACCP as defined in Section 123.3 (k) (1) of the Federal law mandating HACCP, as interpreted by DNREC, shall be required to:

4.1.2.1 Complete an Approved HACCP Training Course; and

4.1.2.2 Develop and implement an Approved HACCP Plan. DNREC may provide guidance in developing this Plan, and may draft the Plan if the person/business is unable for any reason to do so without assistance.

4.2 General Sanitation:

4.2.1 Sanitary Control: All persons/businesses which handle shellfish shall be required to comply with any or all of Section IV of these Regulations.

4.2.2 Sampling: Representatives of DNREC may secure reasonable samples of shellfish for laboratory and sanitary examination.

4.2.3 Adulterated Product: Shellfish shall not be adulterated. Shellfish shall be considered to be adulterated if they contain poisonous or deleterious substances, and/or based on the following criteria:

4.2.3.1 Only processes approved by DNREC may be used in the handling of shellfish.

4.2.3.2 Only shellfish additives approved by DNREC shall be used in shellfish at concentrations approved by DNREC.

4.2.3.3 In addition to other labeling and tagging requirements, shellfish shall be labeled with all required information regarding additives.

4.2.3.4 Shellfish shall meet the bacteriological standards indicated in Appendices 6 and 7.

4.3 Harvesting of Shellfish:

4.3.1 Harvesting For Depuration Or Relay Purposes: Shellfish may be harvested for depuration or relay purposes from waters classified as other-than-Approved; however not from Prohibited waters, and only with written permission of DNREC. Shellfish containing poisonous or deleterious substances shall meet FDA tolerance levels prior to sale to the final consumer.

4.3.2 Waste Disposal:

4.3.2.1 All buy boats shall have a non-receiving-waters-discharge-capable marine head (Type III without a Y-valve) on board.

4.3.2.2 No body excretions shall be discharged overboard from a boat used in harvesting shellfish, or from "buy" boats while in areas from which shellfish are harvested.

4.3.2.3 No other poisonous or deleterious substance shall be discharged overboard.

4.3.2.4 All shellfish harvest vessels shall have at a minimum a bucket with a tight-fitting lid designated exclusively for retention of bodily excretions.

4.3.3 Shellstock Contact Surfaces:

4.3.3.1 Boat decks, storage bins, and other surfaces that contact shellstock shall be constructed of cleanable material(s). Wood which is smooth and cleanable, without cracks and crevices, and is well maintained, shall be considered a suitable shellstock contact surface.

4.3.3.2 Shellstock contact surfaces shall be kept clean with potable water, or with Approved shellfish growing water, and shall be thoroughly cleaned before they contact the shellstock.

NOTE: Shellstock in this case shall mean only live shellfish still in the shell.

4.3.4 Contamination and Temperature Control: NOTE: Shellstock in this case shall mean only live shellfish still in the shell.

4.3.4.1 Dogs, cats or other animals are not permitted on vessels or in vehicles on which shellstock is held.

4.3.4.2 Shellstock shall be covered when ever possible and as soon after harvest as possible to prevent contamination of the shellstock by bird excrement or other contaminants and to reduce exposure to the sun which may cause spoilage.

4.3.4.3 DNREC shall have the authority to require shellfish harvesters to provide adequate temperature controls for shellstock during any phase of handling based on ambient air temperature and time of exposure.

4.3.4.4 Shellstock shall not come in contact with bilge water or any other polluted water. Shellstock shall be stored after harvest in a location that will prevent the shellfish from contacting bilge water or waters classified as other-than-Approved.

4.3.4.5 Shellstock shall be washed reasonably free of bottom sediments and detritus as soon after harvesting as is practical with Approved shellfish growing area water or potable water. The primary responsibility for washing is with the harvester.

4.3.4.6 Sacks or other containers used for storing shellstock shall be clean and fabricated from safe materials. Such sacks/containers shall have only been used for the conveyance of shellfish, and shall not have been used for the conveyance of other food products since their fabrication.

4.3.5 Records: Harvesters shall place tags on individual units of shellstock, recognizing that individual bags or a bulk landing of shellstock may constitute an individual unit of shellstock. All harvester tags shall meet the requirements specified in Appendix 10.

4.4 Post Harvest Handling, Packing, Shipping, and Shucking of Shellfish:

4.4.1 Plant Location/Flooding: Plants in which shellfish are shucked and packed shall be located so they will not be subject to regular flooding. If plant floors become flooded shucking shall be discontinued until after waters have receded, and the building is cleaned.

4.4.2 Plant Arrangement:

4.4.2.1 The handling of shellfish shall be separated by time and/or distance/partitions from other operations which could cause contamination of the shellfish.

4.4.2.2 Packing rooms shall be of sufficient size to permit sanitary handling of the product, and thorough cleaning.

4.4.2.3 A separate room, rooms, or lockers shall be provided for storing employees' street clothing, aprons, gloves, and personal articles.

4.4.2.4 Plants/trucks/conveyances shall be used in a manner which is consistent with plant arrangement requirements, and which provide sanitary protection of the shellfish.

4.4.3 Vectors:

4.4.3.1 Plants/trucks/conveyances shall be constructed so that reasonable barriers to entry are provided for insects, rodents, and other vermin.

4.4.3.2 Extermination efforts shall be required when deemed necessary.

4.4.3.3 Plant premises shall be maintained so that no undue harborage or food is provided for vermin.

4.4.3.4 No domestic animals or fowl shall be permitted in the interior of shellfish processing plants, except guard dogs may be allowed in non-processing portions of plants with no further restrictions, and may be allowed in processing portions of the plant interior when plants are not in use unless the dog's behavior results in chronic unsanitary conditions.

4.4.4 Non-Food Contact Surfaces:

4.4.4.1 Truck floors, storage bins, and other surfaces that contact shellstock shall be constructed of cleanable material(s), shall be kept clean with potable water or Approved shellfish growing water, and shall be thoroughly cleaned before they contact the shellstock.

4.4.4.2 Hardwood in good condition, and smooth and cleanable, shall be considered a suitable shellstock contact surface. NOTE: Shellstock in this case shall mean live shellfish still in the shell.

4.4.4.3 Floors shall be constructed of concrete or other material reasonably impervious to water, shall be graded to drain quickly, shall be free from cracks and uneven surfaces that interfere with proper cleaning or drainage, shall be maintained in good condition, and shall be kept clean.

4.4.4.4 Interior surfaces, including walls, ceilings, refrigeration units, and attached equipment in rooms where shellfish are shucked, packed, or stored, or in which utensils are washed or stored, shall be smooth, washable, light-colored, shall be maintained in good condition, and shall be kept clean.

4.4.4.5 Blow tank air intake filters shall be constructed from approved materials.

4.4.4.6 Surfaces of stands or stalls shall be smooth and cleanable.

4.4.5 General Sanitation:

4.4.5.1 Premises shall be kept clean and free of litter and rubbish. Adequate, covered refuse containers shall be provided throughout the plant. Miscellaneous and unused equipment and articles which are not necessary to plant operations shall not be stored in rooms used for shellstock storage, shucking, packing, or repacking.

4.4.5.2 In addition to being maintained in a generally sanitary condition, non-food contact surfaces, including shucking stools, floors, walls, ceilings, and attached equipment in the shellstock storage rooms, packing, and shucking rooms, shall be cleaned as soon as is practicable after the day's operations have ceased.

4.4.5.3 Adequate cleaning equipment and solutions shall be provided, used, and stored properly.

4.4.5.4 Signs shall be posted in toilet rooms and/or near hand sinks directing employees to wash their hands before starting work and after each interruption.

4.4.5.5 Covered refuse containers shall be provided at each hand sink. Soap and paper towels shall be provided at each hand sink.

4.4.5.6 Windows and skylights (inside and outside surfaces) shall be maintained, and kept in a clean condition.

4.4.6 Lighting: Ample natural and/or artificial light shall be provided in all working and storage rooms. Artificial lighting fixtures shall be shielded.

4.4.7 Heating, Cooling and Ventilation: Working rooms shall be ventilated, and shall be heated or cooled when necessary to prevent condensation.

4.4.8 Water Supply: All Shucker-Packers, Repackers, and Depuration Processors shall have an adequate potable water supply. Shellstock Shippers shall have a potable water supply or access to Approved shellfish growing waters.

4.4.9 Plumbing and Related Facilities:

4.4.9.1 Plumbing shall be installed in compliance with all the BOCA Southern Plumbing Code and local plumbing codes.

4.4.9.2 Toilets shall be easily accessible.

4.4.9.3 Sinks with cold running water, and hot running water of at least 100 Degrees-F, shall be provided for employee use after using the lavatory, and shall be located so they are subject to observation by plant personnel responsible for this task.

4.4.9.4 All toilets, toilet rooms, and outhouses, and all surfaces therein, shall be constructed of smooth and cleanable materials, and shall have toilet paper.

4.4.9.5 All toilet rooms and outhouses shall be vented to the outside.

4.4.9.6 A three compartment sink with hot and cold running water available at each compartment shall be provided on the premises for the purpose of washing, rinsing, and sanitizing equipment which contacts the shellfish, such as knives and shucking buckets.

4.4.9.7 At least one hand sink with hot and cold running water shall be provided in the packing room, and one provided in the shucking room.

4.4.10 Sewage Disposal: Sewage shall be discharged in accordance with the DNREC "Regulations Governing the Design, Installation and Operation of On-Site Waste water Treatment and Disposal Systems." Sewage disposal facilities shall be so constructed and maintained that wastes will be inaccessible to flies.

4.4.11 Food Contact Surfaces:

4.4.11.1 Materials and Construction:

4.4.11.1.1 The tops of shucking benches and tables, and contiguous walls to a height of at least 2 feet above the bench top, shall be of smooth concrete, corrosion-resistant metal, or other durable, non-absorbent material, free from cracks, and so constructed that drainage is complete and rapid, and is directed away from the stored shellfish.

4.4.11.1.2 Equipment and conveyances shall be constructed so shucked shellfish do not become entangled and/or hung up on the equipment during processing operations.

4.4.11.1.3 Shucking blocks shall be smooth and cleanable. Wooden blocks are allowed if smooth and cleanable, and are of solid, one-piece construction, and are easily removable. Shucking blocks of lead and other toxic materials are prohibited.

4.4.11.1.4 Food contact surfaces of refrigeration units, utensils, and other equipment, shall be made of smooth, corrosion-resistant, impervious, nontoxic material which will not readily disintegrate or crack; and utensils and equipment shall be constructed so they are easily cleanable, and shall be kept in good repair.

4.4.11.1.5 Shellstock not shipped in bulk shall be shipped in sacks or other containers approved for storing shellstock, shall be clean, and shall be fabricated from safe materials. NOTE: Shellstock in this case shall mean only live shellfish still in the shell.

4.4.11.1.6 Shucked shellfish shall be packed and shipped in clean, single-service containers made of impervious materials, and which possess tamper resistant qualities, or they shall be stored in clean, properly designed, returnable containers, sealed so that tampering can be detected.

4.4.11.2 Sanitation and Use:

4.4.11.2.1 All food-contact surfaces, including; but not limited to shucking benches, blocks, and other work surfaces, and utensils which come into contact with shucked shellfish, shall all be used in a sanitary manner, stored in a manner which precludes contamination, and shall be washed and rinsed with potable water, and sanitized as soon as is practicable after the day's operations have ceased.

4.4.11.2.2 Returnable shipping containers shall be thoroughly cleaned as soon after emptying as is practical, and shall be washed and rinsed with potable water, and sanitized on the day they are to be used, and shall be protected against contamination, and handled in a sanitary manner.

4.4.11.2.3 All single-service containers shall be stored and handled in a sanitary manner, and where necessary shall be given bactericidal treatment immediately prior to filling.

4.4.11.2.4 Adequate cleaning equipment, solutions, sanitizers, and test kits shall be provided, used, and stored properly.

4.4.11.2.5 Poisonous and Deleterious Substances: Poisonous and deleterious substances shall be properly used, stored, located, and labeled.

4.4.12 Records and Shellstock/Shellfish Labeling:

4.4.12.1 Complete and accurate records of all shellfish received and shipped shall be kept by every shellfish dealer/processor, shall be organized and easily understood pertaining to traceback of shellstock/shellfish to waters of origin, and shall be made accessible to DNREC. Records shall accurately reflect all information required on shellfish tags, as specified in Appendix 10.

4.4.12.2 Shellfish shall not be accepted by shellfish dealer/processors unless the shellfish is identified and accompanied by the information contained in Appendix 10.

4.4.12.3 All shellfish dealer/processors shall retain records of the procurement of and distribution of shellfish/shellstock for a period of at least one year if the product is fresh, and for a period of at least two years if the product is frozen, unless otherwise proscribed by DNREC.

4.4.12.4 Shellfish reshipped or distributed by wholesale dealers shall bear shellfish tags. If the package is reshipped as a unit, remaining unchanged since it was received, the tag shall have sufficient blank space for the reshipper to stamp their reshipper number, state designation, and date of reshipment on the tag.

4.4.12.4.1 Shellstock: All shellfish dealer/processors shall identify each bag, container, or other unit of shellstock with a regulation shellfish tag, as per specifications in Appendix 10.

4.4.12.4.2 Each individual package of fresh or frozen shucked shellfish shall have permanently recorded on the package or label, so as to be easily visible, the shucker-packer's, repacker's, and distributor's name, address, and Interstate Certified Shellstock Shipper's List (ICSSL) certificate number preceded by the abbreviated name of the State. Containers holding 1 gallon or more shall have the identification on the container wall unless the cover becomes an integral part of the container during the sealing process. Packages of frozen shellfish shall show the date or code of packing.

4.4.12.4.3 Each container or unit of shucked shellfish shall be labeled with the information contained in Appendix 10.

4.4.13 Shellstock Handling (General):

4.4.13.1 All shellstock shall be protected against contamination at all times, and shall be handled in a sanitary manner, and shall be shipped, delivered, and received in a clean and wholesome condition.

4.4.13.2 Dead shellstock shall be culled as often as is practicable. Only live shellfish shall be shucked. Dead shellstock shall not be made available for human consumption, and shall be disposed of in a sanitary manner. The exception to these requirements shall be Post-Harvest Processed shellfish / shellstock, where killing the animal is an accepted result of said process(es).

4.4.13.3 There shall be no commingling of shellfish.

4.4.13.4 Shellstock shall be washed reasonably free of bottom sediments and detritus as soon after harvesting as is practicable with Approved shellfish growing water or potable water. Although washing shellstock is the primary responsibility of the harvester, it shall also be the responsibility of the person receiving shellstock to ensure that they are washed.

4.4.13.5 Flume water shall be maintained reasonably free of sediments, shellfish tissue "fines," and other particulate matter, and shall be changed often enough to preclude excessive accumulation of such matter.

4.4.13.6 Shucked shellfish shall not be allowed to become entangled or hung up on equipment for more than 30 minutes during processing operations. Actions shall be taken to dislodge meats from equipment at intervals not to exceed 30 minutes. Such meats may be reintroduced into processing operations. Meats which have become entangled or hung up on equipment for more than 30 minutes shall be dislodged, removed, and discarded.

4.4.13.7 Shells from which meats have been removed shall be removed promptly from the shucking room.

4.4.14 Temperature Control:

4.4.14.1 Adequate refrigeration shall be required, with thermometers and/or temperature recording devices, as required by DNREC.

4.4.14.2 Shellstock: Shellstock shall be transported in adequately refrigerated trucks if, in the opinion of DNREC, not doing so would subject the product to unacceptable bacterial growth or deterioration due to high ambient outside air temperature and/or an unacceptably long transportation time. Within four hours of receipt/loading of shellstock, said shellstock shall be in an environment capable of achieving and maintaining a product temperature of 45^oF or lower.

4.4.14.3 Shucked Shellfish:

4.4.14.3.1 Shucked shellfish shall be cooled to an internal temperature of 45^oF or less within 2 hours after packing. Further cooling to a temperature not exceeding 40^oF is recommended.

4.4.14.3.2 Shellfish which will not be packed within 1 hour after delivery to the packing room shall be cooled to an internal temperature of 45^oF or less within 2 hours, and in all cases shellfish shall be cooled to an internal temperature of 45^oF or less within four hours of commencing processing of said shellfish.

4.4.14.3.3 Flume water shall be maintained at 50^oF or less during processing operations.

4.4.14.3.4 A temperature of 0^oF or less shall be maintained in the frozen-storage rooms.

4.4.14.4 Packing: The temperature of shellfish shall not exceed 50^oF during the repacking process. Frozen shellfish shall not be thawed during repacking. Shucked Shellfish Intended For Repacking: Shucked shellfish that is to be repacked by the receiver shall be received at the repacking plant in approved shipping containers at a temperature of 45^oF or less. Frozen shellfish which have thawed shall not be repacked or repackaged.

4.4.15 Ice: Ice shall be obtained from a source approved by DNREC, and shall be stored and handled in a sanitary manner.

4.4.16 Wet Storage:

4.4.16.1 Shellfish in wet storage shall be protected from contamination.

4.4.16.2 Wet storage is prohibited unless written approval is given each year by DNREC. This approval shall include a sketch, drawn to scale, and attached to or drawn on the reverse side of the certificate, showing the approved location of the wet storage area, float, or the water intake for the wet storage tanks, and shall further show all the potential hazards to which the shellfish may be exposed. The approval statement rendered by DNREC shall describe the measures taken to protect the shellfish from the potential hazards. The written approval for wet storage shall expire concurrently with the expiration of the shellfish permit.

4.4.17 Supervision and Personnel: Supervision shall be adequate to ensure that personnel adhere to the parameters listed below, shellfish are handled/maintained in a sanitary manner, and the premises are maintained in a sanitary manner.

4.4.17.1 Unauthorized persons shall be excluded from the shellfish processing plant and related operations.

4.4.17.2 Any person known to be infected with any disease in a communicable form, or to be a carrier of any disease which can be transmitted through the handling of shellfish, shall be excluded from handling shellfish. Any person who has an infected wound or open lesion on any exposed portion of his body shall be excluded from shucking or packing shellfish.

4.4.17.3 Personnel shall not eat or use tobacco when engaged in shellfish processing operations. Employees shall not use tobacco in any form in the rooms in which shellfish are shucked or packed.

4.4.17.4 Personnel shall maintain their person and outer garments in a clean condition. Any person who handles shucked shellfish shall wear a clean apron or coat.

4.4.17.5 Personnel shall wear clean hair restraints when engaged in shucking or packing shellfish.

4.4.17.6 Employees shall wash their hands with soap and water before beginning work, and again after each interruption.

4.4.17.7 When manual handling of shucked shellfish becomes necessary personnel shall wear sanitized rubber gloves, or shall wash and disinfect their hands immediately prior to such manual handling. Rubber gloves shall be sanitized as often as necessary, and at least twice daily.

4.5 Depuration of Shellfish: This Section is specific to depuration, and applies to depuration-processors in addition to other applicable portions of Sections III and IV of these Regulations.

4.5.1 General Requirements: On a case-by-case basis, DNREC shall require any and all means deemed necessary to ensure that shellfish required to be depurated are subjected to the depuration process approved by DNREC for each depuration-processor.

4.5.2 Process Specifications:

4.5.2.1 In addition to routine permitting and certification procedures, depuration process specifications and physical plant specifications shall be approved by DNREC in cooperation with the depuration processor prior to commencing operations. The depuration process specifications shall substantiate that the depuration process will reduce bacteria and viruses to acceptable levels. Sampling protocols and indicator bacteria standards are located in Appendices 5 and 6.

4.5.2.2 Depuration process lots shall consist of shellfish from the same shellfish growing area or bed. A single process lot may consist of more than one harvest lot only if each harvest lot originates from the same shellfish growing area or bed.

4.5.2.3 Shellfish from different process batches shall be packaged separately.

4.5.2.4 Different shellfish species shall not be processed in the same depuration unit unless studies demonstrate that the species are compatible, and that each species is effectively depurated.

4.5.2.5 Shellfish process lots shall not be commingled during washing, culling, depuration, packing, or any other part of the processing operation. Shellfish harvest lots placed in the same depuration unit, and subsequently shipped all at once or in several batches, shall be considered a single process batch. If more than one harvest lot of shellfish are being processed at the same time the identity of each harvest lot shall be maintained throughout the depuration process.

4.5.2.6 Shellfish shall be depurated for at least 48 hours. Longer depuration times may be required by DNREC.

4.5.2.7 The maximum depth of shellfish in depuration vessels shall be 3 inches for hard clams and oysters, and 8 inches for soft clams.

4.5.2.8 Shellfish shall be washed and culled after depuration, and packaged in clean shipping containers fabricated from safe materials.

4.5.2.9 Processing vessels shall be cleaned, sanitized, and rinsed free of the sanitizer before a process lot is processed.

4.5.2.10 Depurated shellfish shall not be repackaged after leaving the depuration plant.

4.5.3 Process Water Specifications: The process water shall meet the following physical, chemical and microbiological parameters:

4.5.3.1 A minimum Dissolved Oxygen concentration of 50% of saturation;

4.5.3.2 No detectable coliform organisms as measured by the standard five-tube MPN for drinking water, or a test of equivalent sensitivity in the tank influent;

4.5.3.3 A salinity within 20% (+ or -) of the harvest area;

4.5.3.4 A minimum temperature of 50^oF for oysters and hard clams and 35^oF for soft clams and a maximum temperature of 68^oF for hard and soft clams; and